System and method for patient temperature control

ABSTRACT

A patient temperature control system and method are provided for automated temperature control according to a programmed protocol. In one aspect, at least one programmed protocol may be established for each of a plurality of patient thermal therapy phases. In turn, the temperature of a thermal exchange medium may be controlled, based at least in part, upon the programmed protocol, during each of the phases. In another aspect, a plurality of programmed protocols may be established, wherein a selected one of the protocols (e.g. selected by a user at a user interface) may be utilized for automated temperature control during patient thermal therapy. The protocol(s) may include a target patient temperature and/or a set duration for one or more of the phase of thermal therapy. Further, the protocol(s) may be user-definable and modifiable during therapy. In a multi-phase configuration, automatic termination and initiation of successive phases may be selectively established by a user, based on target patient temperature data and/or set duration data on a phase-specific basis.

RELATED APPLICATIONS

This application claims priority to U.S. Patent Provisional ApplicationSer. No. 60/979,760, filed Oct. 12, 2007, entitled “SYSTEM AND METHODFOR PATIENT TEMPERATURE CONTROL”, the entirety of which is herebyincorporated by reference.

FIELD OF THE INVENTION

The present invention relates to an improved system and method forpatient temperature control via temperature control of a thermalexchange medium, including automated thermal control of a plurality oftherapy phases based upon one or more programmed protocols.

BACKGROUND OF THE INVENTION

The therapeutic use of bodily cooling and heating systems, respectively,is ever-increasing. Hypothermia may occur for a variety of reasons,including exposure to cold environments, or complex surgical procedures.

During surgery, a patient typically experiences mild hypothermia as aresult of the effect of general anesthesia on the body'sthermoregulatory system and prolonged exposure of internal organs. Mildhypothermia in a surgical patient has been thought to prolong the timeto extubation, contribute to coagulopathies, increase the chance ofinfection, and increase cardiac demand as a result of shivering. In suchprocedures, controlled patient warming may be of therapeutic benefit.

Hyperthermia may occur as a result of stroke, cardiac arrest and headtrauma. In such cases it is now accepted that rapid cooling can yieldsignificant therapeutic benefits. Specifically, research indicates thateven though a stroke or cardiac arrest victim's brain cells may loosetheir ability to function, the cells do not necessarily die quickly. Infact, brain damage from a stroke or cardiac arrest may take hours toreach maximum effect. Neurological damage may be reduced and the strokeor cardiac arrest victims'outcome improved if a neuroprotectant therapyis applied within this time frame.

Similarly, elements in the genesis of a traumatic brain injury (e.g.,resulting from falls, vehicular accidents and the like) are nowunderstood to overlap with elements in the genesis of neurologicaldamage in stroke victims. In particular, delayed secondary injury at thecellular level after the initial head trauma is now recognized as ameasured contributing factor to the ultimate tissue loss that occursafter brain injury. Again, neurologic damage may be reduced if aneuroprotectant therapy is rapidly applied. Further, in this regard,studies have shown that treatment with mild hypothermia, defined aslowering core body temperature at 2-3° C. confers neuroprotection instroke victims, and may hasten the neurologic recovery and improveoutcomes when applied for 12-72 hours in cases of traumatic head injury.Again, to optimize such therapies, the neuro-protective therapy shouldbe initiated as soon as possible after a stroke or traumatic headinjury.

As reflected by the foregoing, significant therapeutic benefits may berealized through the use of bodily cooling and heating systems. In turn,systems which offer enhanced operational features are of particularinterest as cooling/heating therapy modalities continue to evolve.

SUMMARY OF THE INVENTION

One objective of the present invention is to provide a patienttemperature control system and method that facilitates enhancedreliability.

Another objective of the present invention is to provide an improvedpatient temperature control system and method that is user friendly.

Yet another objective of the present invention is to provide an improvedpatient temperature control system and method that facilitates therealization of enhanced efficiencies of medical care resources.

One or more of the noted objectives and additional advantages may berealized by the system and method of the present invention. Theinventive system may be computer-based to include a user interface forreceiving user control input and for providing corresponding outputsignals to a programmable control module.

In one aspect, the programmable control module may be provided to storecontrol data and apply control logic in the generation of controlsignals in corresponding relation to a plurality of different patienttemperature control phases (e.g. two or more). In this regard, aprogrammable multi-phase control module may be provided to facilitatethe establishment of one or more protocols that each comprise parameterdata for use in the control of patient temperature in each of theplurality of a patient temperature phases.

In another aspect, the programmable control module may be provided tofacilitate the establishment of and to store two or more programmedprotocols comprising control data, wherein the programmable controlmodule may utilize a selected protocol and apply control logic in thegeneration of control signals in a patient thermal therapy procedurecomprising one or more phases. In this regard, the user interface may beprovided to facilitate the establishment of multiple programmedprotocols, and to allow a user to a select a given one of the protocolsfor application in a given patient therapy. By way of example, aplurality of protocols may be pre-established via the user interface,wherein such protocols are each directed to different patient treatmentapplications and/or protocol preferences of medical personnel.

The protocol data for a given phase may comprise a target patienttemperature. Alternatively or additionally, the protocol data for agiven phase may comprise a set duration. In one arrangement, the userinterface may be adapted to receive user input to establish the protocoldata.

For each given protocol, the programmable control module may be adaptedto provide output control signals to a thermal exchanger. In turn, thethermal exchanger may be provided to responsively change the temperatureof a thermal exchange medium to achieve a desired thermal exchange witha patient. By way of example, the thermal exchange medium may comprise afluid (e.g. a circulated liquid and/or gas), wherein componentry of thethermal exchanger operates to change the temperature of the thermalexchange medium in corresponding relation to control signals output fromthe programmable control module.

The patient temperature control system may also include a temperaturesensor to sense the temperature of a patient on an ongoing basis andprovide a corresponding output signal to the programmable controlmodule. In turn, the programmable control module may utilize the patienttemperature measurement signal and target patient temperature protocoldata to generate control signals (e.g. on a single phase or phasespecific basis). Further, the programmable control module may furtheremploy phase duration protocol data in conjunction with the generationof control signals (e.g. on a single phase or phase specific basis).

The user interface and programmable control module may also be adaptedto allow for selective user modification of target patient temperaturedata and/or phase duration data (e.g. on a single phase or phasespecific basis). In turn, a modified protocol may be employed by theprogrammable control module during any remaining portion of a modifiedphase.

The user interface may be further adapted with various numerical andgraphic user interface functionalities. For example, a graphic displaymay be provided to visually present plots of target patient temperatureadjustment rates for one or more patient treatment phases, together witha plot(s) of a measured patient temperature and/or of a measuredtemperature of a thermal exchange medium. As may be appreciated, suchvisual display facilitates medical personnel monitoring of a givenpatient therapy procedure so as to enhance overall control andresponsive action as necessary.

In conjunction with the present invention, an inventive method is alsoprovided for controlling a temperature of a thermal exchange medium in athermal patient temperature control system. Correspondingly, the methodprovides for patient temperature control.

The inventive method may comprise a step of establishing a programmedprotocol for at least one phase of patient thermal therapy. The methodmay further include a step of controlling automatically the temperatureof a thermal exchange medium of a patient temperature control system,based at least in apart on the programmed protocol, for at least aportion of each of the at least one phase.

In one aspect, the programmed protocol may be established to comprise atarget patient temperature and/or a set duration for a plurality ofphases of patient thermal therapy. Such phases may be successive or mayhave one or more therapy phases therebetween.

In another aspect, the establishing step may be repeated a plurality oftimes so as to result in a plurality of programmed protocols. In turn,the method may include a step of selecting (e.g. by a user at a userinterface) one of the plurality of programmed protocols for applicationin the controlling step.

The controlling step may entail setting the temperature of the thermalexchange medium based at least in part upon a measured patienttemperature and a corresponding target patient temperature for a givenphase. By way of example, the temperature of the thermal exchange mediummay be set (e.g. cooled, maintained or heated) pursuant to a comparisonof the measured patient temperature and the corresponding target patienttemperature.

In another aspect, a programmed protocol may be established for at leasttwo successive phases of patient treatment. In turn, the controllingstep may further provide for the automatic termination and initiation,respectively, of first and second ones of the at least two successivephases in response to a comparison of a measured patient temperature anda target patient temperature for the first one of the two successivephases. In another approach, automatic termination and initiation,respectively, of successive phases may occur upon the expiration of aset phase duration comprising the programmed protocol.

In various applications, the programmed protocol may be established tocomprise different target patient temperatures for at least a first setof two of the plurality of phases. Additionally, the programmed protocolmay be established to comprise the same target patient temperature forat least a second set of two of the plurality of phases. In oneembodiment, the plurality of phases may include at least threesuccessive phases, wherein the target patient temperatures for the threephases are established so as to affect a desired degree of patientcooling/heating during a first phase, maintain the patient at acooled/heated temperature during a second phase, and heat/cool a patientat desired rate during a third phase of treatment.

Numerous additional aspects and advantages will be apparent to thoseskilled in the art upon consideration of the further description ofembodiments hereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of a patient temperature controlsystem comprising the present invention.

FIG. 2 illustrates one embodiment of a method for controlling thetemperature of a patient via control of the temperature of a thermalexchange medium included in a temperature control system.

FIGS. 3A-3I illustrate exemplary screens of one embodiment of a userinterface employable in the system embodiment of FIG. 1 and methodembodiment of FIG. 2.

FIGS. 4A-4D illustrate exemplary screens of another embodiment of a userinterface employable in the system embodiment of FIG. 1 and methodembodiment of FIG. 2.

DETAILED DESCRIPTION

FIG. 1 illustrates one embodiment of a patient temperature controlsystem 1 comprising the present invention. The patient temperaturecontrol system 1 may be computer-based to include a user interface 10for receiving user control input and for providing corresponding signals12 to a programmable control module 20. User interface 10 may be furtheradapted to receive signals 14 from the programmable control module 20for use in the display of control and measured data and for operative,interactive interface with a user at user interface 10. In the laterregard, user interface 10 may include an interactive display as furtherdescribed hereinbelow.

The programmable control module 20 may be provided to store data andgenerate signals in corresponding relation to a plurality of differentpatient temperature control phases. Additionally or alternatively, theprogrammable control module 20 may be provided to facilitate theestablishment of one or more programmed protocols that each compriseparameter data for use in the control of each of the plurality ofpatient temperature control phases. By way of example, the protocol maycomprise target patient temperature data for each of a plurality oftreatment phases. Further, for one or more of the phases, the protocolmay comprise a set duration for thermal treatment.

For each given protocol the programmable control module 20 may provideoutput control signals 16 to a thermal exchanger 30 on a phase-specificbasis. In turn, thermal exchanger 30 may be provided to responsivelychange the temperature of a thermal exchange medium 40 to affect adesired thermal exchange, e.g. to cool, maintain the temperature of, orheat a patient. For example, thermal exchange medium 40 may comprise afluid (e.g. a liquid and/or gas), and thermal exchanger 30 may compriseheating and/or cooling componentry which operate to change thetemperature of the thermal exchange medium 40 in corresponding relationto control signals 16 output from the programmable control module 20.

In one approach, the programmable control module 20 may be provided forcooling/heating and circulating water as a thermal exchange medium 40through one or a plurality of fluidly interconnected pads designed forintimate contact with and thermal energy exchange with a patient P, astaught in one or more U.S. Pat. No. 6,669,715 to Hoglund et al.; U.S.Pat. No. 6,827,728 to Ellingboe et al.; U.S. Pat. No. 6,375,674 toCarson; and U.S. Pat. No. 6,645,232 to Carson, all of which are here byincorporated by reference in their entirety.

As illustrated in FIG. 1, the patient temperature control system 1 mayfurther comprise a temperature sensor 50 for measuring the temperatureof the thermal exchange medium 40 on an ongoing basis and providing acorresponding output signal 52 to the programmable control module 20.Further, a temperature sensor 60 may be provided to measure thetemperature of a patient P on an ongoing basis and provide acorresponding output signal to the programmable control module 20. Thetemperature sensor 60 may comprise a sensor to measure a core bodytemerature of the patient P. The output signals 52 and 62 may beemployed by the programmable control module 20, together with protocoldata and preset algorithms, to generate (e.g. via a processor and/orlogic circuit) the control signals 16 provided to thermal exchange 30,so as to yield the desired temperature of thermal exchange medium 40(e.g. on a single phase or phase specific basis).

FIG. 2 illustrates one embodiment of a method 100 for controlling thetemperature of a patient via control of the temperature of a thermalexchange medium included in a multi-phase temperature control system. Asillustrated, the method 100 may include an initial step 102 ofestablishing a protocol that includes target patient temperatures for aplurality of phases (e.g. 2 or more phases having different patienttemperature exchange objectives). Such phases may be successive in timeand/or spaced in time. The establishment of a protocol may be achievedvia use of the programmable control module 20 and operativelyinterconnected user interface 10 of FIG. 1.

By way of example, the protocol may be established to include targetpatient temperatures for at least three phases. Such an approachfacilitates a procedure in which a patient is cooled/heated to a firsttarget patient temperature in a first phase of therapy, maintained at orwithin a predetermined range of a second target patient temperatureduring a second phase (e.g. equal or different than the first targettemperature), and heated/cooled to a third target patient temperatureduring a third phase. In other embodiments, following a third phase oftherapy it may be desirable to establish a fourth target patienttemperature for use in temperature control during a fourth phase oftherapy.

The method may further include a step 104 of controlling the temperatureof a thermal exchange medium of a patient temperature control systembased on the protocol for each of the plurality of phases, e.g. viacontrol of the thermal exchange 30 to control the temperature of thethermal exchange medium 40 of FIG. 1. In this regard, the protocol maybe further established at step 106 so as to include a set duration forone or more of the phases, e.g. via use of a programmable control module20 and user interface 10 of FIG. 1. In turn, the controlling step 104may be carried out during such phase(s) for a duration(s) thatcorrespond with the set duration.

In one approach, the controlling step 104 may be carried out in step 108for each phase by setting the temperature of the thermal exchange mediumbased upon a measured patient temperature and the target patienttemperature for such phase, e.g. via use of a signal from temperaturesensor 50 by the programmable control module 20 of FIG. 1. By way ofexample, the patient temperature may be measured on an ongoing basisduring a given phase and compared to the corresponding target patienttemperature for such phase. Based upon such comparison, a patienttemperature control system may provide for cooling and/or heating of athermal exchange medium according to any of a plurality of pre-setalgorithms, e.g. via control of the heat exchanger 30 by theprogrammable multi-phase control module 20 of FIG. 1.

In one approach, a control algorithm may provide for simply turningon/off a cooling/heating component of a temperature control system inintervals that depend upon a degree of difference reflected bycomparison of the measured patient temperature and target patienttemperature. In another approach, a control algorithm may provide forcontrolling an output magnitude of a cooling/heating component of atemperature control system based upon a degree of difference reflectedby comparison of the measured patient temperature and target patienttemperature.

In another approach, the controlling step 104 may be completed as step110 for a given phase by setting the temperature of a thermal exchangemedium based upon a measured patient temperature, a target patienttemperature for such phase, and a set duration for such phase. Forexample, utilization of the noted parameters accommodates thedetermination and control use of a target patient temperature adjustmentrate for the phase, wherein gradual patient cooling/warming over adesired time period may be facilitated.

In yet another approach, a measured thermal exchange medium temperaturemay be employed together with a measured patient temperature and targetpatient temperature to control the heating/cooling of a thermal exchangemedium. Such an approach may yield enhanced system response.

The illustrated method 100 may further provide for modification of agiven protocol based on user input at step 112, e.g. user input at theuser interface 10 of FIG. 1. In this regard, a modified protocol may beemployed for the remaining duration of a modified phase(s) and any forphase(s) that have not yet been initiated.

In the illustrated method, a given phase may be automatically terminatedat step 114 by expiration of a corresponding set duration includedwithin the programmed protocol for such phase. In this regard, thetermination of a given phase may generally correspond with a change inthe mode (e.g. cooling or heating) or a change in the magnitude ofthermal exchange between a thermal exchange medium and a patient.

Method 100 may also provide for the termination and initiation ofsuccessive phases at step 116 in response to a comparison of a measuredpatient temperature and a target patient temperature. That is, upondetermining that a target patient temperature has been reached during agiven phase (e.g. via comparison of a measured patient temperature and atarget patient temperature for an initial phase of treatment), suchphase may be automatically terminated and a successive phaseautomatically initiated. Alternatively and/or additionally, the method100 may also provide for the termination and initiation of successivephases in response to the expiration of a set duration for a first oneof the two successive phases. The automatic phase termination/initiationfeatures may be selectively established by a user for a given protocolon a phase-specific basis.

FIGS. 3A-3I illustrate an embodiment of an interactive user interface200 operatively interconnected to a programmable multi-phase controlmodule (e.g., module 20 of FIG. 1) for providing phase-related controland alarm data, and measured data, to a user and for prompting andreceiving user control input via interactive screen displays. Thisembodiment contemplates one implementation of the present invention forpatient cooling, e.g. for use in treating stroke, cardiac arrest and/ortraumatic brain injury. Such embodiment is described for purposes ofillustration and it should be understood that additional embodimentsdirected to patient cooling for other conditions (e.g. high fever)and/or patient warming may utilize features analogous to those describedherein.

With particular reference to the interactive screen 202 of userinterface 200 illustrated in FIG. 3A, a plurality of pre-establishedprotocols options may be presented to a user, wherein any one of theprotocol options may be selected for use in a given therapy. By way ofexample, each of the protocol options may be identified (e.g. by a givenname) in corresponding spatial relation to an input selection button,wherein a user may select a mgiven one of a plurality of protocol optionbuttons 220 a, 220 b, 220 c, 220 d or 220 e, e.g. via touch-screenand/or point-and-click functionality.

With reference to FIG. 3B, an interface screen 204 of user interface 200is illustrated that presents data comprising a pre-established controlprotocol corresponding with the protocol option button 220 a of FIG. 3A(i.e. entitled “Dr. Jones SCA”). Such protocol includes phase-specifictarget patient temperature and duration data sets that are presentednumerically in a first portion 210 of the user interface 200 and thatare presented graphically in a second portion 212 of user interface 200,as will be further described. Prior to the initiation of a given phase,the corresponding phase duration presented in the first portion 210 ofuser interface 200 may be the value established in the correspondingprotocol. After initiation of a given phase, the phase durationpresented in the first portion 210 of the interface 200 may be theremaining amount of time, or remaining phase duration, for the givenphase.

Each phase-based set of target patient temperature and phase durationdata may be selectively modified by a user via interactive buttons 232and 234 presented in an interactive region 230 of the first portion 210of user interface 200, e.g. via touch-screen and/or point-and-clickfunctionality. For example, a given data set may be selected andpresented in buttons 232 and 234 via user control of interactive buttons254 and 256, labeled “Next” and “Prev.”, respectively, wherein data setsmay be scrolled across the first portion 210, i.e. from interactiveregion 230 to a non-interactive region 242 or non-interactive region 244(See FIG. 3C). In turn, for a given data set located in active region230, button 232 may be selected to modify a corresponding target patienttemperature and/or button 234 may be selected to modify a correspondinggiven phase duration, as will be further described.

Interactive region 230 of user interface of 200 may also include aninteractive button 236, entitled “Start” and symbolically displayed witharrows in green, for use in starting/restarting a given phase oftherapy, e.g. via touch screen and/or point-and-click functionality.Relatedly, user interface 200 may also include an interactive button238, labeled “Stop” and symbolically displayed in a red octagon, forusing in stopping a given phase of therapy. Additionally, in theillustrated embodiment interface buttons 239 a and 239 b may be providedfor user control over specific interconnected thermal exchange systemfeatures, e.g. filling of a reservoir with a liquid heat exchange mediumthat is circulated through pads contacted with a patient for thermalexchange during system operation, and emptying of the liquid thermalexchange medium from such pads (e.g. into the reservoir upon completionof a given patient therapy).

With particular reference to FIG. 3B, a patient target temperature for“Phase 1”, i.e. “33.0° C.”, is presented in corresponding spatialrelation to user interface button 232. Further, a patient targettemperature for “Phase 2”, i.e. “33.0° C.”,is presented in anon-interactive region 242.

FIG. 3C illustrates an interface screen 206 corresponding with exemplaryPhase 2 operations, and FIG. 3D illustrates an interface screen 208corresponding with exemplary Phase 3 operations. In this regard,interface screen 206 presents a target patient temperature of “33.0° C.”for Phase 2 in interactive region 230, and a target patient temperatureof “33.0” and “36.5” for “Phase 1” and “Phase 3”, respectively, innon-interactive regions 244 and 242, respectively. Similarly, interfacescreen 208 presents a target patient temperature of “36.5° C.” for Phase3 in interactive region 230, and a target patient temperature of “33.0”for Phase 2 in non-interactive region 244.

Screens 204, 206 and 208 of FIG. 3B, FIG. 3C and FIG. 3D also provideprotocol data regarding corresponding set phase durations, or remainingdurations, of Phases 1-3. More particularly, in relation to “Phase 2”and “Phase 3”, the corresponding set durations of “11:00” and “04:30”are presented in the non-interactive informational region 242 of FIGS.3B and 3C, respectively. In FIG. 3C the remaining duration of “Phase 2”is illustrated as “6:05 Hr.”, since a portion of Phase 2 has alreadypassed (i.e. 4 hours and 55 minutes). Similarly, in FIG. 3D theremaining duration of “Phase 3” is illustrated as “00:50 Hr.”, since aportion of Phase 3 has already passed (i.e. 3 hours and 40 minutes).

With respect to FIG. 3B the corresponding phase duration for Phase 1 isa minimum amount of time entailed to lower the temperature of a givenpatient to the target patient temperature for “Phase 1”, i.e. 33.0° C.,with the system operating at pre-set maximum rate. As such, the durationinformation corresponding with “Phase ”1 is presented in duration button236 as “Rapid”.

As noted above, phase-specific target patient temperature and phaseduration data sets may be presented graphically in a second portion 212of user interface 200, as reflected by FIG. 3B, FIG. 3C and FIG. 3D. Inthis regard, the phase-specific target patient temperature and phaseduration data may be utilized to generate a plot of a target patienttemperature level as a function of time-in-therapy. This may becharacterized as a target patient temperature adjustment rate. Forexample, and as shown in FIG. 3B, FIG. 3C, and FIG. 3D atemperature-to-time graphic display region 214 may illustrate a targetpatient temperature plot 260 (e.g. a dashed line), wherein aninteractive button 216 may be utilized to control the units oftemperature display, i.e. ° C. or ° F.

In relation to the target patient temperature plot 260, a first targetpatient temperature for Phase 1 corresponds with the location of a firstplot point 260 a, a second target patient temperature and acorresponding phase duration for Phase 2 correspond with the location ofa second plot point 260 b, a third target patient temperature andcorresponding phase duration for Phase 3 correspond with the location ofa third plot point 260 c, and a fourth target patient temperature for afinal phase corresponds with the location of a fourth plot point 260 d.In relation to Phase 1, the target patient temperature plot portion, orslope, may be generated based upon a starting, measured patienttemperature, the Phase 1 target patient temperature, and a predictedrate of cooling for Phase 1 operations based upon known system coolingparameters. In short, the plot position for Phase 1 reflects a predictedpatient temperature adjustment rate.

As illustrated in FIG. 3B, FIG. 3C and FIG. 3D, user interface 200 mayalso be provided to numerically display a measured patient temperatureon an ongoing basis in the second portion 212. Similarly, user interface200 may be provided to numerically present a measured water temperature(e.g. as employed as a thermal exchange medium) on an ongoing basis.

In this regard, user interface 200 may be adapted to graphicallypresent, or plot, the measured patient and water temperatures on anongoing basis in the graphic display region 214. By way of example, FIG.3C and FIG. 3D illustrate a measured patient temperature plot 252 (e.g.a relatively thin line) and a measured water temperature plot 262 (e.g.a relatively thick line), both in time-based relation to the targetpatient temperature plot 260. Further, the graphic display region 214may be selectively expanded via user interface with a button 218entitled “EXPAND GRAPH”, wherein the plots 252, 260 and 262 may bedisplayed in relation to an expanded graph. Additionally, the graphicdisplay region 214 may be provided to visually indicate which of aplurality of therapy phases is currently in process. For example, inFIG. 3B a portion of the graphic display region 214 may be presented ina different manner (e.g. a different color) than the rest of the display(e.g. as indicated by angled lines in FIG. 3B) to indicate that “Phase1” has been or is about to be initiated. Similarly, in FIG. 3C a portionof graphic display region 214 visually indicates that “Phase 2” iscurrently-in-process (e.g. via a different color than the rest of thedisplay as reflected by the diagonal lines of FIG. 3C), and in FIG. 3Dgraphic display region 214 visually indicates that “Phase 3” isunderway.

Of note, the measured patient temperature plot 252 and target patienttemperature plot 260 may each be graphically presented in correspondingunit relation to a first temperature scale, i.e. “PATIENT TEMP ° C.” asprovided along the left side of the graphic display region 214. Suchcorresponding unit relationship may be further visually highlighted fora user by presenting the “PATIENT TEMP ° C.” indicator and temperatureunit measures, e.g. “30” to “40” in FIG. 3C in a color (e.g. yellow) orother unique manner that corresponds with the color (e.g. yellow) orother unique manner of display for the measured patient temperature plot252 and target patient temperature plot 260.

Further, the measured water temperature plot 262 may be graphicallypresented in corresponding unit relation to a second temperature scale,i.e. “WATER TEMP ° C.”, as provided along the right side of the graphicdisplay region 214. Such corresponding unit relationship may be furthervisually highlighted for a user by presenting the “WATER TEMP ° C.”indicator and temperature unit measures, e.g. “4” to “44” in FIG. 3C, ina color (e.g. blue) or other unique manner that corresponds with thecolor (e.g. blue) or other unique manner of display for the measuredwater temperature plot 262, and that is otherwise different from thecolor (e.g. yellow) or manner of display for the measured patienttemperature plot 252, target patient temperature plot 262 and theircorresponding unit indicators.

Of further note, it may be noted that the scaling of the above-notedunit temperature measures along the left side and right side of thegraphic display region 214 may be different. Such difference in scalingaccommodates differences between the measured/target patient-relatedtemperature indicator and the measured water-related temperatureindicators. For example, in relation to FIG. 3C, the measured/targetpatient related-temperature indicator range is from 30° C. to 40° C.,while the measured water related-temperature indicator range is from 4°C. to 44° C. By accommodating such range differences, the measured andtarget patient-related temperature plots may more noticeably reflectsmaller degrees of temperature change. More generally, and as may beappreciated, many of the other display capabilities described abovefacilitate user visual monitoring and attendant responsive control of apatient therapy session.

In this regard, and as previously noted, the phase-specific targetpatient temperature and phase duration data of a given protocol may bemodified in a given case utilizing buttons 232 and 234, respectively.For example, when button 232 illustrated in FIG. 3B is selected by auser, a screen 210 may be displayed as shown in FIG. 3E. In turn,magnitude control buttons 270 a, 270 b may be utilized to change thetarget patient temperature for Phase 2 to a desired magnitude, and thenapplied or cancelled via selection of button 272 a entitled “OK” orbutton 272 b entitled “Cancel”.

Similarly, when button 234 illustrated in FIG. 3B is selected by user, ascreen 212 may be displayed as shown in FIG. 3F. In turn, magnitudecontrol button 274 a, 274 b may be utilize to change the phase durationof Phase 2 and then applied or cancelled via selection of button 276 aentitled “OK” or button 276 b entitled “Cancel”. Upon modification oftarget patient temperature protocol data or a phase duration protocoldata by a user, the interconnected programmable multi-phase controlmodule will control the cooling/heating of the thermal exchange mediumin accordance with the modified protocol data. Correspondingly, the userinterface 200 may be adapted so that the target patient temperature plot260 on the graphic display 214 will automatically reflect such changes.

Returning now to FIG. 3A, interactive screen 202 includes an interactivebutton 222 entitled “Advanced Set-Up” for use in establishing one ormore protocols. In particular, upon user selection of the interactivebutton 222, an interactive screen 290 may be presented as illustrated inFIG. 3G. In turn, upon user selection of a given menu list item by auser (e.g. via touch screen or point-and-click functionality), furthercorresponding screens may be presented. For example, upon selection ofthe menu item “Set-Up Protocols”, a user may access a plurality ofscreens to establish a name of a protocol, and corresponding controldata and alarm condition data on a phase-specific basis.

In this regard, control functionality may be included in variousembodiments that provides for the establishment of a protocol tofacilitate phase-specific patient therapy in one of either a manual modeor an automatic mode of operation for each given phase of patienttreatment. In one embodiment, subsequent to selection of the “Set-UpProtocols” menu item of screen 290 of FIG. 3G, a user may proceed toestablish control and alarm condition data for a given phase (e.g. Phase1, Phase 2 etc.) wherein a pop-up window may be presented (not shown)that allows a user to select one of either an “Automatic” mode or a“Manual” mode of operation for the given phase.

By way of example, upon selection of a “Manual” mode option for Phase 1operation, a screen 292 may be presented as shown in FIG. 3H. Moreparticularly, interactive screen 292 may be provided to receive userinput parameters in a plurality of fields 280 a, corresponding with aplurality of data types indicated by corresponding data field names 282a. In the later regard, the data field names 282 a, may be displayed ina manner that prompt a user to input corresponding data into fields 280a, (e.g., by blinking and/or being displayed in a preset color until thedata is entered).

In the illustrated embodiment of FIG. 3H, two optional pre-setconditions may be set by a user in relation to Phase 1—Manual modeoperations. First, a user may establish a first condition, e.g. viaselection of a “Y” option as opposed to a “N” option, to automaticallyswitch from Phase 1—Manual mode operation to a next phase of operation,e.g. Phase 2, upon the expiration of a set duration of Manual modeoperation. In the illustrated embodiment, such “Duration” has beeninputted as protocol data by a userto be “1:00 Hr.”. As furtherillustrated, a second condition may be selected by a user, e.g. theselection of “Y” as opposed to a “N” option, to automatically switchfrom the Phase 1—Manual mode of operation to a next phase of operation,e.g. Phase 2, upon system receipt and processing of a measured patienttemperature signal that indicates that a patient has “stabilized” interms of physiological temperature response.

As further reflected by FIG. 3H, a user may input control dataestablishing a target temperature for a thermal exchange medium, e.g. awater target temperature, wherein during the Manual mode a patienttemperature control system will cool/heat the thermal exchange medium ata predetermined maximum rate to reach the set thermal exchange mediumtemperature (e.g. “4.0 C” for the “Water target”), and will continue tooperate at the set temperature until the mode is terminated.

Upon user selection of an “Automatic” mode option for Phase 1 operation,a user a screen 294 may be presented as shown in FIG. 3I. Moreparticularly, interactive screen 294 may be provided to receive userinput parameters in a plurality of fields 280 b, corresponding with aplurality of data types indicated by corresponding data field names 282b. In the later regard, the data field names 282 b may be displayed in amanner that prompt a user to input corresponding data into fields 280 b(e.g., by blinking and/or being displayed in a preset color until thedata is entered).

By way of example, the input parameters may include protocol controldata to set a patient target temperature, e.g. the patient targettemperature of Phase 1 in the displayed embodiment has been set by auser at “33.0° C.”, and a set phase “Duration”. Further, the userinterface 200 may provide for user input regarding automatic terminationof Phase 1—Automatic mode and initiation of Phase 2 operations upon oneof two alternate pre-set condition(s) being met. First, a user mayestablish a first pre-condition (e.g., via selection of a “T” option),to automatically “jump” from Phase 1—Automatic mode operation to Phase 2operation when a measured patient temperature reaches the protocolpatient target temperature for Phase 1, i.e., “37.0 C”. Alternatively, auser may establish a second pre-condition, e.g., via selection of a “D”option, to jump from Phase 1—Automatic mode operation to Phase 2operation upon the expiration of the protocol set duration of Phase 1.In the illustrated embodiment, such set duration has been inputted bythe user to be “6:00 Hr”. Alternatively, a user may establish, e.g. viaselection of a “N” option, that automatic jumping is not desired.

As further reflected by FIGS. 3H and 3I, user interface 200 may befurther provided to allow for user input to establish phase-specific,e.g. phase-mode-specific, alarm condition data. In particular, inrelation to the Phase 1—Manual mode of operation, a patient hightemperature alert level, e.g., “40.0 C”, and a patient low temperaturealert level, e.g., “33.0 C” may be set. Similarly, in relation to thePhase 1—Automatic mode of operation, a patient high temperature alertlevel, e.g. “40.0 C”, and a patient low temperature alert level, e.g.33.0 C” may be set. In turn, during a given mode when a measured patienttemperature signal goes outside of the corresponding high/low range ofpatient temperature, user interface 200 may be adapted to provide analert output to a user. For example, a pop-up window and/or audibleoutput alert may be provided to a user that not only alerts the user tothe presence of an alarm condition, but also informs the user as to theparticular condition and identifies potential remedial user responseoptions. Such functionality may be extended to thermal exchange mediumtemperature limits, e.g. water high temperature and water lowtemperature, alarm condition alert levels for application in Phase1—Automatic mode operations, as indicated in FIG. 3H.

In addition to Phase 1 protocol control and alarm condition data, itshould be appreciated that the user interface 200 may provide additionalscreens similar to screens 292 and 294 that provide for the entry ofprotocol control data and alarm condition data for one or moreadditional phases of operation. In this regard, a user may pre-establishdata for multiple phases, as may be desired by a given practitioner.

FIGS. 4A-4D illustrate selected aspects of another embodiment of aninteractive user interface 300 operatively interconnected to aprogrammable control module (e.g. module 20 of FIG. 1) for providingphase-related control and alarm data, and measured data, to a user andfor interfacing with a user to receive control input via variousinteractive screen displays. This embodiment contemplates animplementation of the present invention directed to two alternativepatient therapy protocols, i.e. for normothermia therapy and forhypothermia therapy (e.g. for use in treating stroke, cardiac arrestand/or traumatic brain injury). Again, such embodiments are describedfor purposes of illustration and additional embodiments will be apparentto those skilled in the art.

With particular reference to the interactive screen 302 of userinterface 300 illustrated in FIG. 4A, two alternate protocol options maybe presented to a user for use in a given therapy procedure. As shown,the two alternate options are entitled “NORMOTHERMIA CASE” and“HYPOTHERMIA CASE”, wherein a user may select a given one of the twooptions utilizing buttons 320 a or 320 b, e.g. via touch-screen and/orpoint-and-click functionality.

With reference to FIG. 4B, an interface screen 304 of user interface 300is illustrated that presents data comprising a pre-established controlprotocol corresponding with the protocol option button 320 b of FIG. 4A(i.e. entitled “HYPOTHERMIA CASE”). Such protocol includes twophase-specific target patient temperature and duration data sets thatare presented numerically in interactive display regions 330 and 342 ofuser interface 300.

Each phase-based set of target patient temperature and phase durationdata may be selectively modified by a user via interactive buttons 332 aand 332 b, as presented in the interactive regions 330 and 342, viatouch-screen and/or point and click functionality. More particularly, agiven data set may be adjusted utilizing button 332 a or 332 b entitled“ADJUST”, and immediately applied utilizing button 334 a or 334 bentitled “START”. In the former regard, for example, for the coolingphase corresponding with interactive region 330, the correspondingtarget patient temperature and phase duration data may be adjusted viauser interface with button 332 a to access pop-up window 370 shown inFIG. 4C. In turn, control buttons 372 may be utilized to adjust theparameters and control button 374 entitled “SAVE” may be employed tosave the adjusted parameters.

With further reference to FIG. 4B, phase-specific target patienttemperature and phase duration data may be utilized to generate a targetpatient temperature adjustment rate plot 360 that is presentedgraphically in a graphic display region 312 of the user interface 300.As may be appreciated, measured patient temperature data and measuredwater temperature data may also be numerically displayed and utilized togenerate corresponding plots for display in the graphic display region312, in a manner analogous to that described in relation to theembodiment of FIGS. 3A-3I addressed above. Further, the graphic displayregion 312 may visually highlight a phase that is currently in process,e.g. via color differentiation for such phase in corresponding relationto a color utilized in the phase-oriented interaction regions 330 and342.

Reference is again made to FIG. 4A, wherein interactive screen 302includes an interactive button 322 entitled “ADVANCED SET-UP” for use inestablishing the two optimal protocols. In particular, upon selection ofthe interactive button 322, an interactive screen 390 may be presentedas illustrated in FIG. 4D. In turn, the various interactive controlbuttons presented on screen 394 may be utilized to establish parametersand protocol control data in a manner analogous to that described abovein relation to FIGS. 3G, 3H and 3I. In this regard, such user controlmay be facilitated via the consistent intuitive use of an “ADJUST”button to access pop-up windows that are easy to employ, as per thepop-up window shown in FIG. 4C above.

The various embodiments described above are for purposes of illustrationand are not intended to limit to scope of the present invention.

What is claimed is:
 1. A method for controlling a temperature of athermal exchange medium of a patient temperature control system,comprising: establishing a programmed protocol in response to user inputat a user interface for each of a plurality of phases that arenon-overlapping in time, said plurality of phases including at least twosuccessive phases, wherein a target patient temperature is establishedin response to said user input for each of said plurality of phases, andwherein a set phase duration is established in response to said userinput for at least one of said plurality of phases; receiving a sensoroutput signal of a measured patient temperature on an ongoing basis,wherein said measured patient temperature is a measured core bodytemperature; and, controlling automatically a temperature of a thermalexchange medium of a patient temperature control system, based at leastin part upon said programmed protocol, during at least a portion of eachof said plurality of phases, wherein for each given phase of saidplurality of phases said controlling comprises comparing said measuredpatient temperature to said corresponding target patient temperature forsaid given phase, and wherein said controlling further comprises bothautomatically terminating and initiating together, respectively, a firstphase and a second phase of said at least two successive phases upon adetermination by said comparing that said measured patient temperaturehas reached the target patient temperature for said first phase of saidat least two successive phases.
 2. A method as recited in claim 1,wherein for said at least a portion of each of said plurality of phasessaid controlling step further comprises: setting automatically saidtemperature of the thermal exchange medium based at least in part uponsaid measured patient temperature and said corresponding target patienttemperature comprising said programmed protocol.
 3. A method as recitedin claim 1, said establishing step further comprising: establishing saidprogrammed protocol in response to user input at said user interface tocomprise different target patient temperatures for at least a first setof two of said plurality phases.
 4. A method as recited in claim 3, saidestablishing step further comprising: establishing said programmedprotocol in response to user input at said user interface to comprisethe same target patient temperatures for at least a second set of two ofsaid plurality of phases.
 5. A method as recited in claim 4, whereinsaid plurality of phases comprises at least three successive phases, andwherein said phases comprising said first set of two of said pluralityof phases are successive and automatically terminated and initiatedtogether, and said phases comprising said second set of two of saidplurality of phases are successive and automatically terminated andinitiated together.
 6. A method as recited in claim 1, wherein said atleast one of said plurality of phases is said second phase of said atleast two successive phases, said establishing step further comprising:establishing said programmed protocol in response to said user input atsaid user interface to comprise a set phase duration for at leastanother one of said plurality of phases; and, wherein said controllingfurther comprises both automatically terminating and initiatingtogether, respectively, said second phase and said at least anotherphase of said plurality of phases upon expiration of said set phaseduration for said second phase of said plurality of phases.
 7. A methodas recited in claim 6, wherein for said at least another one of saidplurality of phases, said controlling step further comprises: settingautomatically said temperature of the thermal exchange medium based atleast in part upon both said corresponding set phase duration and saidcorresponding target patient temperature comprising said programmedprotocol.
 8. A method as recited in claim 1, said establishing stepfurther comprising: receiving said user input in predeterminedcomputerized record fields.
 9. A method as recited in claim 1, saidestablishing step further comprising: repeating said establishing stepto establish a plurality of programmed protocols; and providing saiduser interface for user selection of one of said plurality of programmedprotocols for use in said controlling step.
 10. A method as recited inclaim 1, further comprising: outputting to a user at said userinterface, during at least a portion of at least any one of saidplurality of phases, information based upon: a target patienttemperature adjustment rate for said at least any one of said pluralityphases; and, at least one of the following: said ongoing measuredpatient temperature; and an ongoing measured temperature of said thermalexchange medium.
 11. A method as recited in claim 10, said outputtingstep comprising: displaying said information at said user interface. 12.A method as recited in claim 11, said displaying step comprising:presenting said information in a plurality of different plots, whereineach of said plurality of different plots are presented on a graphictemperature/time scale basis.
 13. A method as recited in claim 10,further comprising: determining automatically said target patienttemperature adjustment rate based at least in part upon said programmedprotocol.
 14. A method as recited in claim 10, further comprising one ofthe following: determining automatically said target patient temperatureadjustment rate based at least in part on said target patienttemperatures comprising said programmed protocol for successive ones ofsaid plurality of phases; and determining automatically said targetpatient temperature adjustment rate based at least in part on saidtarget patient temperature for said at least one of said plurality ofphases and said measured patient temperature.
 15. A method as recited inclaim 1, further comprising: outputting to a user at said userinterface, during at least a portion of said at least two successivephases, information based upon: a target patient temperature adjustmentrate for said at least two successive phases; and, at least one of thefollowing: said ongoing measured patient temperature; and an ongoingmeasured temperature of said thermal exchange medium; wherein saidinformation is presented in a plurality of different plots, wherein eachof said plurality of different plots are presented on a graphictemperature/time scale basis.
 16. A method as recited in claim 1,further comprising: modifying said programmed protocol for at least oneof said plurality of phases, after said establishing step, in responseto user input at said user interface prior to completion of said atleast one of said plurality of phases; and using automatically saidmodified programmed protocol in said controlling step in completing saidat least one of said plurality of phases.
 17. A method as recited inclaim 16, said modifying step comprising: displaying at said userinterface at least one of said target patient temperature and said setphase duration for said at least one of said plurality of phases;providing an interactive user control for direct modification anddisplay, in response to user input at user interface, of said at leastone of said target patient temperature and said set phase duration forsaid at least one of said plurality of phases.
 18. A method as recitedin claim 1, said establishing further comprising: setting at least onealarm condition specific to at least any one and less than all of saidplurality of phases in response to user input at said user interface;and monitoring automatically a condition corresponding with said atleast one alarm condition during said at least any one and less than allof said plurality of phases.
 19. A method as recited in claim 18,further comprising: providing automatically an alarm output to a user inresponse to said monitoring step during said at least any one and lessthan all of said plurality of phases.
 20. A method for controlling atemperature of a thermal exchange medium of a patient temperaturecontrol system, comprising: establishing a plurality of programmedprotocols, wherein for each one of the plurality of programmed protocolsa corresponding protocol is established in response to user input at auser interface for each of a corresponding plurality of phases that arenon-overlapping in time, each of said corresponding plurality of phasesincluding at least two successive phases, wherein a target temperatureis established for at least one of said corresponding plurality ofphases, and wherein a set phase duration is established for at least oneof said corresponding plurality of phases, receiving a sensor outputsignal of a measured patient temperature on an ongoing basis, whereinsaid measured patient temperature is a measured core body temperature;and, controlling automatically a temperature of a thermal exchangemedium of a patient temperature control system based at least in partupon the programmed protocol corresponding with a selected one of saidplurality of programmed protocols, wherein for each given phases of saidcorresponding plurality of phases for the selected one of said pluralityof programmed protocols said controlling comprises comparing saidmeasured patient temperature to said corresponding target patienttemperature for said given phase, and wherein said controlling comprisesboth automatically terminating and initiating together, respectively, afirst phase and a second phase of said corresponding at least twosuccessive phases upon a determination by said comparing that saidmeasured patient temperature has reached the target temperature for saidfirst phase of said at least two successive phases.
 21. A method asrecited in claim 20, further comprising: providing a user interfaceadapted for user selection of said selected one of the plurality ofprogrammed protocols for use in said controlling step.
 22. A method asrecited in claim 20, wherein for each one of the plurality of programmedprotocols said one of said corresponding plurality of phases is saidsecond one of said at least two successive phases of said correspondingplurality of phases, and wherein said selected one of said plurality ofprogrammed protocols comprises a set phase duration for another one ofsaid corresponding plurality of phases.
 23. A method as recited in claim20, wherein for each of said plurality of phases corresponding with saidselected one of the plurality of programmed protocols said controllingstep further comprises: setting automatically said temperature of thethermal exchange medium based at least in part upon said measuredpatient temperature and said corresponding target patient temperature.24. A computer-based system for controlling a temperature of a thermalexchange medium of a patient temperature control system, comprising: auser interface for receiving user input and providing correspondingoutput signals; and, a programmable control module for receiving asensor output signal of a measured patient temperature that is ameasured core body temperature, and for receiving said output signals toestablish a programmed protocol by storing control data in correspondingrelation to each of a plurality of different patient temperature controlphases that are non-overlapping in time, said plurality of differentpatient control phases including at least two successive phases, whereina target patient temperature is established in response to said userinput at said user interface for each of said plurality of differentpatient control phases, wherein a set phase duration is established inresponse to said user input at said user interface for at least one ofsaid plurality of different patient control phases, and wherein saidprogrammable control module comprises control logic for utilizing saidstored control data to provide output control signals to a thermalexchanger of a patient temperature control system in correspondingrelation to each of said plurality of different patient temperaturecontrol phases; wherein for each given phase of said plurality ofdifferent patient temperature control phases said programmable controlmodule control logic is operable to compare a measured patienttemperature to said corresponding target patient temperature for saidgiven phase, and wherein said programmable control module control logicis operable to both automatically terminate and automatically initiatetogether, respectively, a first phase and a second phase of said atleast two successive phases upon a determination by said comparison ofsaid measured patient temperature to said corresponding target patienttemperature for said given phase that said measured patient temperaturehas reached the target patient temperature for said first one of said atleast two successive phases.
 25. A system as recited in claim 24,wherein said programmable control module is operable to store at leasttwo protocols comprising corresponding, different control data, andwherein said user interface is employable by a user to select either ofsaid at least two protocols for use by said programmable control modulein generating said output control signals.
 26. A system as recited inclaim 24, wherein said user interface is employable to modify saidcontrol data stored by said programmable control module.
 27. A system asrecited in claim 24, wherein said user interface includes: a graphicdisplay to visually present a plot of a target patient temperatureadjustment rate based on said stored control data.
 28. A system asrecited in claim 27, wherein said graphic display is operable to displaya plot of said measured patient temperature in corresponding timerelation to said plot of said target patient temperature adjustmentrate.
 29. A system as recited in claim 28, wherein said graphic displayis operable to display a plot of a measured temperature of a thermalexchange medium employed in said patient temperature control system incorresponding time relation to said plot of said target patienttemperature adjustment rate.
 30. A method as recited in claim 1, whereinsaid plurality of phases includes at least three successive phases, andwherein for a third one of said at least three successive phases, saidcontrolling step further comprises: setting said temperature of thethermal exchange medium based at least in part upon both a correspondingset phase duration and corresponding target patient temperaturecomprising said programmed protocol.
 31. A method as recited in claim30, wherein for said third one of said at least three successive phasessaid controlling step further comprises: comparing said measured patienttemperature to said target patient temperature; and automaticallyterminating said third one of said at least three successive phases atleast partially in response to said comparing step.
 32. A method asrecited in claim 8, wherein said establishing step further comprises:presenting a screen at said user interface in relation to each of theplurality of phases, wherein for each of the plurality of phases saiduser interface is adapted to receive user input parameters in aplurality of predetermined fields, to establish at least one of apatient high temperature alert level and a patient low temperature alertlevel, and at least one of a thermal exchange medium high temperaturelimit and a thermal exchange medium low temperature limit.
 33. A methodas recited in claim 32, wherein said controlling automatically utilizesan established value for said at least one of a thermal exchange mediumhigh temperature limit and a thermal exchange medium low temperaturelimit during said first phase.
 34. A method as recited in claim 12,wherein said presenting step comprises: presenting said plurality ofdifferent plots in a graphic display region in relation to a commonhorizontal time scale.
 35. A method as recited in claim 34, wherein saidpresenting step comprises: presenting said target patient temperatureadjustment rate and said ongoing measured patient temperature inrelation to a first temperature scale on a first side of said graphicdisplay region; and, presenting said ongoing measured temperature ofsaid thermal exchange medium in relation to a second temperature scaleon a second side of said graphic display region.
 36. A method as recitedin claim 18, wherein said at least one alarm condition is one of thefollowing: a patient high temperature alert level; and, a patient lowtemperature alert level.